Lombart Lenses, Ltd.
Country not established
- Devices
- 6
What Lombart Lenses, Ltd. makes
Lombart Lenses, Ltd. manufactures contact lenses designed for daily wear, including single-vision and bifocal variants. Their portfolio includes methafilcon A-based lenses, polymacon polymer components, and finished contact lenses for ocular use. Additional products include lathed lens blanks and specialized polymer buttons for lens fabrication.
The company’s devices are regulated under FDA classifications, with some authorised as Class II and others as Class III. These products are listed via the FDA’s 510(k) and PMA pathways, indicating their compliance with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
Ll-55 (Methafilcon A) For Daily Wear Ref K941877
Regimes: 510(k) Registry: 510(k)Ll Bi-Focal, Daily Wear Contact Lens Ref K971647
Regimes: 510(k) Registry: 510(k)Soft-55 Daily Wear Contact Lens Ref K961428
Regimes: 510(k) Registry: 510(k)Finished Methafilcon A Contact Lenses Ref P890049
Regimes: PMA, withdrawn Registry: PMA- Regimes: PMA Registry: PMA
Saulfon Pw-70 A&B Ref P840031
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Lombart Lenses, Ltd. have in the registry?
The registry currently lists 6 devices for Lombart Lenses, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lombart Lenses, Ltd.'s devices?
Among its 6 most recently registered devices, Lombart Lenses, Ltd. has devices listed in FDA 510(k) (3 devices) and FDA PMA (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Lombart Lenses, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Lombart Lenses, Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Lombart Lenses, Ltd. in the registry?
The most recently registered devices listed for Lombart Lenses, Ltd. include LL-55 (METHAFILCON A) FOR DAILY WEAR, LL BI-FOCAL, DAILY WEAR CONTACT LENS, SOFT-55 DAILY WEAR CONTACT LENS and FINISHED METHAFILCON A CONTACT LENSES.